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US-based online store iHerb has suspended sales of melatonin gummies to Australia. This comes after a rise in reports of non-fatal overdoses in Western Australia in children who took these popular supplements.
This latest move raises fresh concerns about the safety of these non-prescription sleep aids.
I have been a sleep researcher and a psychologist treating children with behavioural sleep problems for more than 20 years.
Here’s what’s great and not so great about using melatonin to help children sleep.
What is melatonin? Who uses it?
Melatonin is a naturally occurring hormone secreted in our brains. Its main function is to make us feel sleepy. A synthetic version is used in prescription and non-prescription products, for adults and for children who have trouble sleeping.
Melatonin prescriptions for children and adolescents with sleep difficulties have increased substantially around the world in recent years.
Melatonin available on prescription is an effective and relatively safe drug in children, particularly those with attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder. It is now the most commonly prescribed drug to treat insomnia in children and adolescents with neurodevelopmental disorders.
These children commonly have considerable difficulties getting to sleep or getting back to sleep when they wake in the night. This can be distressing for the child and the whole family.
Guidelines for melatonin for these children suggest a low dose and only using it for a maximum of two years. Melatonin does not appear to be addictive. So it seems like a good option for these families.
A rise in wider use
Up to one in four children have behavioural sleep problems, including children who are not neurodivergent or who are developing typically.
So parents have turned to sourcing non-prescription melatonin, including melatonin gummies.
However, unlike for neurodivergent children, there are no scientific studies and therefore no evidence to demonstrate whether melatonin would work or pose a risk in typically developing children. There’s certainly no indication of how much children should take and for how long.
So melatonin is not usually recommended for children who are not neurodivergent.
Yet, it is widely available
In many countries, including Australia, melatonin is classified as a pharmaceutical product. In Australia, the Therapeutic Goods Administration approves paediatric use for children with ADHD, autism and Smith-Magenis syndrome, and only on prescription.
In other countries, notably the United States, melatonin is categorised as a dietary supplement and is thought to be natural and safe. As such, it is less tightly regulated than a pharmaceutical product.
As it’s available online, parents in countries with tighter restrictions, including Australia, can buy child-friendly melatonin gummies from the US, for example, and have them shipped. They can do this without a prescription or medical guidance.
Are melatonin gummies safe?
Accessing these gummies online for children without a prescription is at best concerning and at worst dangerous.
We don’t know how much melatonin is in these gummies. Studies show levels vary between brands of melatonin supplements and within the same brand. Melatonin levels range from practically zero to four times more than the amount stated on the label.
Some products also contained serotonin, which is concerning as this can interact with melatonin, and also affect a child’s mood.
There are also a few studies on the long-term effects of taking melatonin, or what is a safe dose. So the risk of overdose is a real concern.
Symptoms depend on many factors, including the age of the child. Symptoms include significant nausea, excessive sleepiness and migraine. The potential effects on other body systems and hormones have not been studied.
There have been deaths and hospital visits associated with the use of melatonin gummies in the US. There have been seven deaths in young children where the link to gummies has been suspected but not substantiated.
In Australia, there have been reports of a rise in queries about gummi overdoses to a poisons hotline.
There’s also the risk of toxicity with melatonin use. But there’s much we don’t know about how this happens, over what time frame, or its effects.
Labels don’t always reflect what’s in the product, so we don’t know if toxicity in children relates to those who have taken what’s recommended on the packet or who have taken too many gummies by accident.
Melatonin gummies look like lollies. What child would not love to eat as many lollies as they can? If you think your child has eaten too many gummies, they need emergency care.
So what are parents to do?
Sleep difficulties can be extremely distressing for the child and the whole family. But we need to treat melatonin with care. Buying melatonin gummies online is not the answer, despite many parents thinking they are safe and natural.
A medical professional can assess if a melatonin prescription is right for your child. They will also support you by recommending behavioural sleep strategies we know work, are sustainable and safe.
(The article has been written by Sarah Blunden, the Professor and Head of Paediatric Sleep Research, CQUniversity, Australia, for The Conversation. The article has been published under Creative Commons — Attribution/No derivatives license.)